BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 5473369 · Received March 2, 2016

    Report

    Report Number
    2649622-2016-02742
    Event Type
    Malfunction
    Date Received
    March 2, 2016
    Date of Event
    February 26, 2016
    Report Date
    May 10, 2016
    Manufacturer
    MPRI
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3058, SERIAL# (B)(4), PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID NEU_WRENCH_ACC, PRODUCT TYPE: ACCESSORY. PRODUCT ID 3058, SERIAL# (B)(4), PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. ANALYSIS OF THE LEAD (L/N VA10K5T) FOUND NO SIGNIFICANT ANOMALIES. THE DISTAL END OF THE LEAD WAS STRETCHED. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE (REP) REGARDING A LEAD WIRE ISSUE. IT WAS REPORTED THAT THERE WAS LEAD INSERTION DIFFICULTY DURING PROCEDURE; THE REP STATED THE HEALTHCARE PROVIDER (HCP) WAS HAVING T ROUBLE INSERTING THE LEAD WIRE, AND THAT THE LEAD WOULDN'T GO IN ALL THE WAY. THERE SEEMED TO BE MORE PLASTIC ON THE 3RD ELECTRODE AND THE HCP EVEN TRIED TO SHAVE SOME PLASTIC OFF. THE HCP TRIED TORQUING THE LEAD WHILE INSERTING, AND ALSO WETTING THE LEAD WITH STERILE NONIONIC WATER, BUT THAT STILL DIDN'T WORK. THE REP HAD ALREADY TRIED OPENING TWO NEW IMPLANTABLE NEUROSTIMULATORS (INS) WITH BOTH DEVICES HAVING ISSUES WITH THE LEAD NOT BEING ABLE TO GO IN ALL THE WAY. THE HCP CONFIRMED THE HEADER BORE WAS CLEAR AND THE SET SCREW WAS BACKED OUT OF THE BORE, WHICH DID NOT RESOLVE THE ISSUE. VISUAL INSPECTION OF THE LEAD CONFIRMED THE LEAD WAS ROUND WITH NO EDGES STICKING OUT, BUT THE 3RD ELECTRODE SEEMED TO HAVE EXTRA PLASTIC ON IT. THE REP OPENED A NEW LEAD WIRE AND TRIED TO INSERT IT INTO THE INS AND IT INSERTED FINE; THE HCP WAS TO INSERT THE NEW LEAD IN THE PATIENT (PT). IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131075 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MPRI 3889-28 VA10K5T

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR